Regulatory Affairs

  • Location: BRUXELLES
  • Type: Contracting
  • Job #16551

Regulatory Affairs

Bruxelles – contracting 

#RA #CMC #Pharma

You have an experience in regulatory affairs in the pharma sector? Our partner is looking for a Regulatory Affairs to join its team. This international company is well known for its vaccines.

What are your responsibilities?

You will have an operational role by doing the execution of European Regulatory CMC strategies, submissions, and compliance activities for biopharmaceutical projects from development to market and post-marketing :

  • You will prepare CMC information for submission to EU regulatory agencies;
  • You will generate CMC strategies, assess risks and develop contingency plans; 
  • You will ensure that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements;
  • You will support the preparation of interfaces with Board of Health – including scientific reviewers and administrative staff – in order to define regulatory applications.

Who are you?

  • You have a scientific degree;
  • You are an experienced regulatory CMC professional or an individual with regulatory expertise in specific regulatory domain;
  • You have knowledge in pharmaceutical sciences with a clear understanding of drug development of biopharmaceuticals;
  • You have the ability to interpret and apply global CMC regulatory policies and requirements for assigned projects;
  • You are fluent in English;
  • You have leadership skills, an excellent cross-cultural awareness and an excellent communication.

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected] or 0498/50.55.53

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!